SOP for Dispensing and Issuing of Packing Material as Per Production Requirement : Pharmaceutical Guidelines

SOP for Dispensing and Issuing of Packing Material as Per Production Requirement

Standard operating procedure of dispensing and issuing of Packing Material as per the requirement from Production Department.

1.0 OBJECTIVE

To lay down a procedure for dispensing and issuing of Packing Material as per the requirement from Production Department.

2.0 SCOPE

This SOP shall be applicable for all packing material which is dispensed and issued to Production Department by Stores Department.

3.0 RESPONSIBILITY

Stores Assistant/Officer

4.0 ACCOUNTABILITY

Head of Department

5.0 PROCEDURE

5.1 Production department shall give Bill of Material / Material Requisition sheet well in advance to stores department.
5.2 After getting Bill of Material/Material Requisition sheet from Production dept., store person shall check the availability of approved material for the respective batch in SAP.
5.3 If any material found still lying in under test, the store person inform to Q. C. immediately.
5.4 The store person shall ensure that all the Packing Material is to be issued as per quantity mentioned in Bill of Material / Material Requisition Sheet.
5.5 Store person shall ensure that approved packing material of appropriate Art Work / Sub Code is to be issued and by maintaining FAFO system.
5.6 If Production Head required other A.R no. the material, then current A.R. No. Stock shall be kept aside and new A.R. No. shall be issued with proper justification by Production and Q.A. Manager. Proper justification Note/Deviation report shall be maintained.
5.7 In case of aluminum foil / PVC film, store person shall dispensed the required quantity by weighing and record the same quantity in requisition slip (Foil Issue Record). In case of extra quantity issued due to intact foil roll issuance, actual issued quantity will be recorded after verification of partial quantity returned from production.
5.8 In case of other printed packaging material, an intact pack is issued considering the quantity as per supplier label and left quantity is issued by manual counting.
5.9 Loose quantity is packed in a separate polybag before issuing to Packing Department and loose quantity left is also packed in polybag with UNDER USE (Loose Quantity) label.
5.10 Keep issued material on separate pallet affixed with the dispensing slip to the dispensed material.

5.11 All issued material is transferred to packing area along with Original and Duplicate Bill of Material. The packing person shall return the duplicate copy as receipt of material after signing the same to stores dept. for necessary entries.
5.12 Material issued from outside store area will be brought in a closed trolley. The issued material will be taken inside the plant by de-dusting the boxes and wrappers in which the material is transferred.
5.13 Store person shall take the entries of the issued material.
5.14 If additional material is required by packing dept., The store person shall ensure that the material is to be issued with proper additional requisition/extra material requisition sheet duly authorized by Production Head and QA Head.
5.15 A.R. wise reconciliation is to be done after consumption of particular A.R. No. (A.R. wise Reconciliation).

6.0 ABBREVIATIONS

6.1 SOP – Standard operating procedure
6.2 QC – Quality control
6.3 QA – Quality assurance
6.4 PVC – Poly vinyl chloride

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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1 comment: Post Yours! Read Comment Policy ▼

  1. I have been reading this blog for the past 6 years and feel that you are doing a wonderful job and I would like to thank you that.
    There are a few points I would like to state about the SOP. I don' think point 5.3 and 5.6 need to mentioned in the SOP. 5.3 would lead auditors to believe that labels are not changed from Quarantine to Passed on-line OR it might also mean that a Bill of Materials can be generated even if a packaging material is still under Quarantine.
    5.6 is covered under Handling of Deviations SOP.
    I had another question? What is the procedure for dispensing primary Packaging materials? I have learnt that in some companies, the primary packaging materials like foil, PVC, Bottles are dispensed in the same way as APIs. Please share your thoughts on this.

    ReplyDelete


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